…we operate a quality management system that has received numerous customer commendations.

Quality is taken extremely seriously at Hugo Technology, as we understand that it some situations, it can be a matter of life and death. As a result, we have appointed global giants BSI as our notified body, who rigorously manage our accreditation to the ISO 13485:2016 quality standards. Our accreditation through BSI also makes the approval of Hugo Technology as a supplier far easier for our customers, especially those based in the United States.

Quality management is carried out across the Hugo organisation on a daily basis, which includes activities such as process design and procedure writing, data analysis and performance measurement, employee training, internal auditing at both departmental and individual levels, QC inspection, risk management in accordance with ISO 14971:2012, facilities maintenance and equipment calibration, and the analysis of feedback from our stakeholders such as our customers and workforce.

The Hugo QMS

Constructed in-house and developed over several years, Hugo operates a quality management system that has received numerous customer commendations.

The advantage of our quality system is that it brings all of the components required for the delivery of a quality service together in one place, so we can be confident in delivering a consistent service that meets our customer’s requirements.

Using our internal on-line quality system, all Hugo employees regardless of location can view aspects such as documented procedures, original device service manuals and OEM work instructions, training records, internal audit reports, KPI data, risk assessments, and customer complaints and non-conformance reports.

The final advantage of our in-house system is that is gives us flexibility to make any required changes that would enable us to accommodate new contracts or strengthen our existing services.

ISO 13485:2016 Overview

  • Incorporation of risk-based approaches beyond product realization. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements
  • Increased linkage with regulatory requirements, particularly for regulatory documentation
  • Application to organizations throughout the life cycle and supply chain for medical devices
  • Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard
  • Emphasis on appropriate infrastructure, particularly for production of sterile medical devices, and addition of requirements for validation of sterile barrier properties
  • Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design transfer and design records
  • Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, and consideration of post-market surveillance
  • Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay